Health Products and Food Branch

Health Products and Food Branch
The Health Products and Food Branch (HPFB) of Health Canada manages the health-related risks and benefits of health products and food by minimizing risk factors while maximizing the safety provided by the regulatory system and providing information to Canadians so they can make healthy, informed decisions about their health.
HPFB has ten operational Directorates with direct regulatory responsibilities:
Biologics and Genetic Therapies Directorate
Food Directorate
Marketed Health Products Directorate (with responsibility for post-market surveillance)
Medical Devices Directorate
Natural Health Products Directorate
Office of Nutrition Policy and Promotion
Pharmaceutical Drugs Directorate
Policy, Planning and International Affairs Directorate
Resource Management and Operations Directorate
Veterinary Drugs Directorate
Extraordinary Use New Drugs
Extraordinary Use New Drugs (EUNDs) is a regulatory programme under which, in times of emergency, drugs can be granted regulatory approval under the Food and Drug Act and its regulations. An EUND approved through this pathway can only be sold to federal, provincial, territorial and municipal governments. The text of the EUNDs regulations is available.
On 25 March 2011 and after the pH1N1 pandemic, amendments were made to the Food and Drug Regulations (FDR) to include a specific regulatory pathway for EUNDs. Typically, clinical trials in human subjects are conducted and the results are provided as part of the clinical information package of a New Drug Submission (NDS) to Health Canada, the federal authority that reviews the safety and efficacy of human drugs.
Health Canada recognizes that there are circumstances in which sponsors cannot reasonably provide substantial evidence demonstrating the safety and efficacy of a therapeutic product for NDS as there are logistical or ethical challenges in conducting the appropriate human clinical trials. The EUND pathway was developed to allow a mechanism for authorization of these drugs based on non-clinical and limited clinical information. A manufacturer of a new drug may file an extraordinary use new drug submission for the new drug if, under paragraph C.08.002.01(1):
International agreements
The HPFB signed an electronic data interchange agreement with the US Food and Drug Administration in November 2003, and again in April 2004 with the Therapeutic Goods Administration of Australia. Dr Joel Lexchin found the secrecy arrangements in the memorandum of understanding to be troublesome and said that "that just makes it more difficult for the medical community to know how drugs were approved, how the data were assessed, and even what data were assessed."
In 2016, the HPFB signed an agreement with the European Directorate for the Quality of Medicines "for the exchange of information generated by the EDQM through its certification procedure and by HBFB during the course of applicable product assessments."
See also
List of food safety organisations
Regulation of therapeutic goods
References
External links
Health Products & Food Branch
Health Canada
Food safety
Product testing
Drug control law
Drug safety
Life sciences industry
Pharmaceuticals policy